envafolimab plus docetaxel in combination with or without trilaciclib versus docetaxel in advanced nsclc

Conditions: Advanced Non-Small Cell Lung Cancer

Summary: to evaluate the efficacy and safety of envafolimab plus docetaxel in combination with or without trilaciclib versus docetaxel in patients with advanced non-small cell lung cancer previously treated with a pd-1 inhibitor combined with chemotherapy

trilaciclib indication: trilaciclib, a cdk4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression, approved by fda and nmpa for small cell lung cancer in 2021 and in 2022. envafolimab indication: envafolimab, a pd-l1 inhibitor, was used for unresectable or metastatic, msi-h or dmmr, adult patients with advanced solid tumors, approved by nmpa in 2021.

Eligibility criteria:
inclusion criteria: * male or female subjects aged≥ 18 years old * metastatic or advanced (stage iv) nsclc confirmed by tissue or pathology * patients with advanced nsclc who had previously failed treatment with platinum-containing chemotherapy combined with pd-1 inhibitor * disease must be measurable by response evaluation criteria in solid tumors version 1.1 (recist 1.1).,and has at least one measurable lesion * patients with asymptomatic brain metastasis or whose symptoms are stable after treatment * patients who responded to initial therapy or whose disease was stable for at least 3 months * laboratory tests met the following criteria: 1. hemoglobin (hb)≥100 g/l(female), ≥110g/l(male) 2. neutrophils (anc)≥1.5×109/l 3. platelet count (plt)≥100×109/l 4. cr≤ 15mg/l or crcl≥ 60 ml/min 5. tbil≤ 1.5×uln 6. alt and ast ≤ 3 × uln or ≤5× uln(patients with liver metastases) 7. albumin ≥ 30 g/l * eastern cooperative oncology group performance status (ecog ps) of 0 to 1 * estimated life expectancy of more than 12 weeks * women: all women with potential fertility must have negative serum pregnancy tests during the screening period and must have reliable contraception after signing the informed consent form until 3 months after the last dose * already signed an informed consent form exclusion criteria: * diagnosis of other malignancies than nsclc within 5 years prior to the first dose administration (excluding radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ) * toxicity not recovered to ≤ grade 1 from prior anticancer therapy * previous treatment with pd-l1 inhibitors * ≥grade 3 immune-related adverse reactions have occurred during previous pd-1 inhibitors treatment * patients with known or suspected interstitial pneumonia * patients with known positive driving genes(egfr,alk,ros1) * have used or requirement of treatment with prednisone \> 10 mg/day or equivalent systemic corticosteroids within 14 days prior to the first dose of study drug * administration of live attenuated vaccines within 28 days prior to the first study drug treatment or planned administration during the study * uncontrolled ischemic heart disease or clinically significant congestive heart failure (nyha grade iii or iv) * have stroke or cardiovascular events within 6 months prior to enrollment * qtcf\>480 msec or qtcf\>500 msec(patients with ventricular pacemakers) * patients who have received hematopoietic stem cell or bone marrow transplants * allergic to the study drug or its ingredients * any other circumstances in which the researcher believes that the patient is not suitable to participate in this study

Keywords: trilaciclib envafolimab nsclc second-line treatment